Trial Outcomes & Findings for Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT (NCT NCT02914509)

NCT ID: NCT02914509

Last Updated: 2021-10-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 565 participants
• Primary outcome timeframe: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit
• Results posted on: 2021-10-11

Participant Flow

Participant milestones

Measure	OTX-TP Three forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) Two hundred seventeen (217) subjects were randomized to the PV.
Overall Study STARTED	348	217
Overall Study COMPLETED	343	211
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

Baseline characteristics by cohort

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n=348 Participants Three hundred forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) n=217 Participants Two hundred seventeen (217) subjects were randomized to the PV.	Total n=565 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	160 Participants n=93 Participants	91 Participants n=4 Participants	251 Participants n=27 Participants
Age, Categorical >=65 years	188 Participants n=93 Participants	126 Participants n=4 Participants	314 Participants n=27 Participants
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=93 Participants	65 years STANDARD_DEVIATION 11 • n=4 Participants	65 years STANDARD_DEVIATION 11 • n=27 Participants
Sex: Female, Male Female	185 Participants n=93 Participants	135 Participants n=4 Participants	320 Participants n=27 Participants
Sex: Female, Male Male	163 Participants n=93 Participants	82 Participants n=4 Participants	245 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	247 Participants n=93 Participants	159 Participants n=4 Participants	406 Participants n=27 Participants
Race/Ethnicity, Customized African American	84 Participants n=93 Participants	48 Participants n=4 Participants	132 Participants n=27 Participants
Race/Ethnicity, Customized Other	17 Participants n=93 Participants	10 Participants n=4 Participants	27 Participants n=27 Participants
Region of Enrollment United States	348 participants n=93 Participants	217 participants n=4 Participants	565 participants n=27 Participants

PRIMARY outcome

Timeframe: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit

Outcome measures

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n=343 Participants Three hundred forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) n=211 Participants Two hundred seventeen (217) subjects were randomized to the PV.
Mean IOP 4PM	19.5 mmHg Standard Error 0.2	21.5 mmHg Standard Error 0.2
Mean IOP 8AM	21 mmHg Standard Error 0.2	22.9 mmHg Standard Error 0.2
Mean IOP 10AM	20.2 mmHg Standard Error 0.2	21.9 mmHg Standard Error 0.2

PRIMARY outcome

Timeframe: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit

Outcome measures

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n=343 Participants Three hundred forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) n=211 Participants Two hundred seventeen (217) subjects were randomized to the PV.
Mean IOP 8AM	21.9 mmHg Standard Error 0.2	26.9 mmHg Standard Error 0.3
Mean IOP 10AM	25.1 mmHg Standard Error 0.2	25 mmHg Standard Error 0.2
Mean IOP 4PM	24.8 mmHg Standard Error 0.2	24.6 mmHg Standard Error 0.2

PRIMARY outcome

Timeframe: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit

Outcome measures

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n=343 Participants Three hundred forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) n=211 Participants Two hundred seventeen (217) subjects were randomized to the PV.
Mean IOP 8AM	22.8 mmHg Standard Error 0.2	23.2 mmHg Standard Error 0.3
Mean IOP 10AM	21.7 mmHg Standard Error 0.2	22.5 mmHg Standard Error 0.2
Mean IOP 4PM	21.4 mmHg Standard Error 0.2	22.1 mmHg Standard Error 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 23 months

Number of Participants with Serious Adverse Events

Outcome measures

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n=348 Participants Three hundred forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) n=217 Participants Two hundred seventeen (217) subjects were randomized to the PV.
Number of Participants With Serious Adverse Events	7 Participants	6 Participants

Adverse Events

OTX-TP (Sustained Release Travoprost) Intracanalicular Depot

Serious events: 7 serious events

Other events: 132 other events

Deaths: 1 deaths

Placebo Vehicle (PV)

Serious events: 6 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n=348 participants at risk Three hundred forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) n=217 participants at risk Two hundred seventeen (217) subjects were randomized to the PV.
Nervous system disorders Serious Adverse Event	0.57% 2/348 • through study duration, an average of 23 months	0.00% 0/217 • through study duration, an average of 23 months
Infections and infestations Serious Adverse Event	0.29% 1/348 • through study duration, an average of 23 months	0.92% 2/217 • through study duration, an average of 23 months
Cardiac disorders Serious Adverse Event	0.29% 1/348 • through study duration, an average of 23 months	0.46% 1/217 • through study duration, an average of 23 months
Respiratory, thoracic and mediastinal disorders Serious Adverse Event	0.00% 0/348 • through study duration, an average of 23 months	0.46% 1/217 • through study duration, an average of 23 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Serious Adverse Event	0.29% 1/348 • through study duration, an average of 23 months	0.00% 0/217 • through study duration, an average of 23 months
Vascular disorders Serious Adverse Event	0.29% 1/348 • through study duration, an average of 23 months	0.00% 0/217 • through study duration, an average of 23 months
Skin and subcutaneous tissue disorders Serious Adverse Event	0.29% 1/348 • through study duration, an average of 23 months	0.00% 0/217 • through study duration, an average of 23 months
Ear and labyrinth disorders Serious Adverse Events	0.00% 0/348 • through study duration, an average of 23 months	0.46% 1/217 • through study duration, an average of 23 months
Injury, poisoning and procedural complications Serious Adverse Event	0.00% 0/348 • through study duration, an average of 23 months	0.46% 1/217 • through study duration, an average of 23 months

Other adverse events

Measure	OTX-TP (Sustained Release Travoprost) Intracanalicular Depot n=348 participants at risk Three hundred forty eight (348) subjects were randomized to OTX-TP	Placebo Vehicle (PV) n=217 participants at risk Two hundred seventeen (217) subjects were randomized to the PV.
General disorders Adverse Event	37.9% 132/348 • through study duration, an average of 23 months	30.0% 65/217 • through study duration, an average of 23 months

Additional Information

Clinical Project Manager

Ocular Therapeutix, Inc.

Phone: 781-357-4000

Email: clinicalaffairs@ocutx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER